UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007786 |
|---|---|
| Receipt number | R000009176 |
| Scientific Title | "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis " |
| Date of disclosure of the study information | 2012/04/19 |
| Last modified on | 2016/04/19 13:29:29 |
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Basic information
Public title
"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis
"
Acronym
Effect examination of infliximab to an anti-TNF invalid example
Scientific Title
"Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis
"
Scientific Title:Acronym
Effect examination of infliximab to an anti-TNF invalid example
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Other TNF inhibitor are prescribed for the patient as the 1st selection, IFX is prescribed for the patient to effect insufficiency or the case which carried out effect decrease, and a follow-up survey of the validity is conducted.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the remission rate of 1-2years after(DAS28(4)-CRP<2.3 or DAS28(4)-ESR<2.6 or SDAI<3.3 or CDAI<2.8)
Key secondary outcomes
the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10
the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
infliximab plus methotrexate
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient whom is prescribing TNF inhibitors other than infliximab for the patient, and the disease activity (DAS28(4)-ESR >3.2, SDAI>11, or CDAI>10) more than the degree of middle class is maintaining over 12 or more weeks
Key exclusion criteria
"1) The patient who is having infliximab medical treatment already experienced
2) The patient who cannot prescribe a methotrexate tablet for the patient
3) The patient who is experienced in TNF inhibitors as for more than 2 agent
4) In addition, the patient who judged that a research doctor was unsuitable "
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Amano |
Organization
Saitama Medical Center. Saitama Medical University
Division name
Division of Rheumatology and Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA
TEL
0492283859
amanokoi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Amano |
Organization
Saitama Medical Center. Saitama Medical University
Division name
Department of Rheumatology & Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA
TEL
0492283859
Homepage URL
amanokoi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center. Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical Universitity
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 19 | Day |
Last modified on
| 2016 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009176
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
